Vimovo MR Tablets

Vimovo is an anti-inflammatory painkiller intended to treat pain from inflammatory conditions. It’s a good fit for conditions like rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It combines effective pain relief with stomach lining protection to reduce the risk of stomach irritation and ulcers.

Vimovo comes in the form of a modified release (MR) tablet to release the active ingredient slowly. This ensures more even distribution and a longer-lasting effect.

How Does Vimovo MR Work?

Vimovo's dual formulation has two active ingredients that target the source of pain, while protecting your stomach. The first active ingredient is Naproxen. This is an anti-inflammatory painkiller in the group of medicines called NSAIDs. These work by suppressing the enzymes that cause your body to produce prostaglandins, the chemicals behind your inflammatory response. However, NSAIDs can also reduce your stomach's protective barrier, making it more vulnerable to acid and ulcers.

Esomeprazole is a proton pump inhibitor (PPI). This inhibits your body's production of excess stomach acid, helping to prevent irritation when you need longer-term pain relief.

How To Take Vimovo

You should always take Vimovo MR tablets as prescribed by our clinical team.

The usual dose is one tablet twice a day, taken at least 30 minutes before food, as food can make both the pain relief and stomach protection less effective.

Always swallow the tablet whole with water. Do not crush or chew it.

Try to take your doses at the same time every day to keep it working through your system and reduce the risk of missed or forgotten doses.

Ingredients

The active ingredients of Vimovo MR tablets are 500 mg of naproxen and 20 mg of esomeprazole magnesium trihydrate.

Other inactive ingredients include croscarmellose sodium, microcrystalline cellulose, magnesium stearate, povidone K90, colloidal silicon dioxide, carnauba wax, glycerol monostearate 40-55, hypromellose type 2910 (3 mPas, 6 mPas and 50 mPas), iron oxide (E172, yellow, black), macrogol 8000, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methyl parahydroxybenzoate (E218), polydextrose, polysorbate 80, propylene glycol, propyl parahydroxybenzoate (E216), sodium laurilsulfate, titanium dioxide (E171) and triethyl citrate.

The inactive ingredients form the tablets' coating and assist in the slow release of active ingredients.

Side Effects

Like all medicines, Vimovo can cause side effects although not everyone will experience them.

The most common side effects are mild and temporary and include indigestion, constipation, diarrhoea, wind, headaches, feeling thirsty and nausea.

Some people may experience dizziness, dry mouth, weight loss, joint pain or skin rashes. Serious side effects are rare but can include flu-like symptoms, stomach bleeding or severe skin reactions.

If you experience worrying side effects, stop taking Vimovo immediately and get in touch with our clinical team.

If you experience black stools, vomiting of food or blood, chest pain, shortness of breath or swelling of the face, lips, tongue or throat, seek urgent medical help.

For further information on less common side effects, please see the Patient Information Leaflet.

Warnings

You should not take Vimovo modified-release tablets if:

• You are allergic (hypersensitive) to naproxen.
• You are allergic to esomeprazole or other proton pump inhibitor medicines.
• You are allergic to any of the other ingredients of this medicine (listed in Section 6).
• You are taking a medicine called “atazanavir” or “nelfinavir” (used to treat HIV).
• If acetylsalicylic acid (e.g. aspirin), naproxen or other NSAIDs such as ibuprofen, diclofenac or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have caused you to have asthma (wheeziness) or an allergic reaction such as itchiness or skin rash (urticaria).
• You are in the last 3 months of pregnancy or you are breastfeeding.
• You have severe problems with your liver, kidney or heart.
• You have an ulcer in your stomach or gut.
• You have any bleeding disorder or serious and unexpected bleeding.

You should discuss taking Vimovo with your regular doctor if:

• You are in the first or second trimester of pregnancy.
• You have inflammation of your intestines (Crohn’s disease or ulcerative colitis).
• You have any other problems with your liver or kidneys or if you are elderly.
• You are taking medicines such as corticosteroids taken by mouth, warfarin, clopidogrel, Selective Serotonin Re-uptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin) or NSAIDs including COX-2 inhibitors (see section Other medicines and VIMOVO).
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazole (which is a component of VIMOVO) that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

You must not take Vimovo and talk to your doctor straight away if any of the following happen to you before or while you are taking Vimovo, as this medicine may hide the symptoms of another disease:

• You lose a lot of weight for no reason and have problems swallowing.
• You start to vomit food or blood.
• You pass black stools (blood-stained faeces).

Other Medicines

Vimovo can affect the way some other medicines work and some other medicines can affect the way Vimovo works. For this reason, you should not take this medicine and speak to your regular doctor if you are taking:

• A medicine called “atazanavir” or “nelfinavir” (used to treat HIV).
• Acetylsalicylic acid (aspirin). If you take low dose acetylsalicylic acid (aspirin) you may still be able to take VIMOVO.
• Other NSAID medicines (including COX-2 inhibitors).
• Certain drugs such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat infections caused by a fungus).
• Erlotinib (or another anticancer drug from the same class).
• Cholestyramine (used to reduce cholesterol).
• Clarithromycin (used to treat infection).
• “Quinolone antibiotic” (for infections), such as ciprofloxacin or moxifloxacin.
• Diazepam (used to treat anxiety, to relax your muscles or used in epilepsy).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Lithium (used to treat some types of depression).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer).
• Probenecid (for gout).
• “Selective Serotonin Reuptake Inhibitors” (SSRIs) (used to treat major depression or anxiety disorder).
• Ciclosporin or tacrolimus (medicines used to dampen down the body’s immune reactions).
• Digoxin (used to treat heart disorders).
• Sulphonylureas such as glimepiride (oral medicines used to control your blood sugar in diabetes).
• Medicines used to treat high blood pressure called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan) and beta-blockers (such as propranolol).
• Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
• Medicine to stop your blood clotting, like warfarin, dicoumarol, heparin or clopidogrel.
• Rifampicin (used for the treatment of tuberculosis).
• St. John’s Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazole (used for pain in the legs due to poor blood flow).

Other Warnings

If you have previously experienced stomach ulcer or bleeding you should let your doctor know. You will be asked to report any unusual symptoms from your stomach (e.g. pain) to your doctor.

Medicines such as Vimovo may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long lasting treatment. Do not exceed the recommended dose or length of treatment.

Vimovo contains the NSAID naproxen. As for all NSAIDs, naproxen should be used at the lowest effective dose for the shortest duration possible to reduce the risk of undesirable effects. Your doctor will, therefore, assess at a regular interval whether Vimovo is still appropriate for you.

Vimovo is not suitable to achieve rapid relief of acute pain, as it takes several hours before the painkilling substance naproxen is taken up in your blood.

Also, check with your doctor before taking this medicine if you have any heart problems, previous stroke or think you might be at risk of these problems. You may be at risk of getting these problems if:

• You have high blood pressure.
• You have problems with your blood circulation or with your blood clotting.
• You have diabetes.
• You have high cholesterol.
• You are a smoker.

Taking a proton pump inhibitor (which is a component of Vimovo), especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Vimovo. Remember to also mention any other ill effects like pain in your joints.

Food and Drink

Do not take Vimovo with food as this may reduce and/or delay the effect of Vimovo. Take your tablets at least 30 minutes before you have a meal.

Vimovo contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These ingredients may cause allergic reactions. These reactions may not happen straight away.

For full information on the warnings and contraindications for Vimovo, please see the Patient Information Leaflet